Health TrialsbyHealthPanel

To Evaluate the Efficacy and Safety of an Defocus Lens in Slowing the Progression of Myopia

ConditionMyopia, Progressive
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-13
SponsorTianjin Eye Hospital

About this trial

To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective, single-centre, randomised, double-blind, controlled, non-inferiority clinical study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The subjects had spherical RE of -1.00 to -6.00 D, astigmatism ≤ 1.50 D, anisometropia ≤ 1.50 D

the best corrected visual acuity in the left and right eyes subjective optometry is greater than or equal to 1.0

Disqualifiers

Candidate subjects were excluded from the study if they had strabismus, ocular limitations, or systemic abnormalities affecting vision and ocular motility

Trial design

Design model

Parallel

Treatments tested in this trial

  • frame lens

    Device

    A randomized block group design was used to randomly assign the included study subjects. The appropriate randomization number and random allocation scheme will be given after enrollment.

Treatment groups

138 Participants
are divided into 3 treatment groups
Group A: Test group A (strong higher-order aberrations group)Experimental treatment 1 intervention
Group B: Test group B (medium higher-order aberrations group)Experimental treatment 1 intervention
Group C: control groups（HOYA MiYOSMART）Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cycloplegic objective refraction

Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan)

Time frame
12 months

Secondary outcomes

1

Axial Length

Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Eye Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: